Quality Assurance at Taj Pharma’s OSD & External Preparation Plant

Taj Pharma: Leading High-Quality Pharmaceutical Manufacturing

At Taj Pharma’s Sarigam facility, Quality Assurance (QA) is the cornerstone of all operations, ensuring that every product—whether oral solid dosage (OSD) or external preparation—meets the highest international quality, safety, and efficacy standards. The QA department functions independently, acting as a gatekeeper between production and the marketplace, with complete oversight of GMP compliance, documentation, process validation, and product release.


1. Total cGMP Compliance

Taj Pharma’s QA operations are conducted in strict accordance with:

  • WHO-GMP
  • PIC/S
  • EU-GMP (pending)
  • ISO 9001:2018 & ISO 9001:2015
  • ICH guidelines for quality

Regular internal audits, vendor qualifications, and mock inspections ensure readiness for global regulatory inspections and uphold Taj Pharma’s reputation as a trusted contract manufacturing partner.

Total cGMP Compliance at Taj Pharma: Ensuring Global-Standard Pharmaceutical Manufacturing

Taj Pharma’s commitment to current Good Manufacturing Practices (cGMP) is foundational to its operations at the Sarigam OSD & External Preparation Plant. The Quality Assurance (QA) team ensures that every manufacturing process, system, and documentation procedure aligns with globally accepted regulatory frameworks and best practices—establishing the facility as a benchmark in pharmaceutical compliance and operational excellence.


International Regulatory Alignment

Taj Pharma’s QA framework adheres to a comprehensive set of quality standards, including:

  • WHO-GMP (World Health Organization – Good Manufacturing Practices): Ensures that pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use and as required by market authorizations.
  • PIC/S (Pharmaceutical Inspection Co-operation Scheme): Harmonizes GMP standards among international health authorities, enhancing mutual recognition and compliance for easier global market access.
  • EU-GMP (European Union Good Manufacturing Practice) – Pending Approval: Demonstrates Taj Pharma’s advanced compliance systems and infrastructure readiness for exporting to stringent regulated markets across Europe.
  • ISO 9001:2018: Supports a structured and continually improving quality management system focused on risk-based thinking, customer satisfaction, and efficient processes.
  • ICH Q-series Guidelines: Incorporates ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System), emphasizing lifecycle management and quality by design (QbD).

Robust Internal Quality Systems

To enforce these standards, Taj Pharma integrates a series of proactive and preventive quality mechanisms:

  • Internal GMP Audits: Scheduled audits across departments help identify non-conformities, gaps, or deviations. Corrective and preventive actions (CAPA) are implemented promptly to mitigate risks and enhance quality assurance systems.
  • Vendor Qualification & Periodic Audits: All raw material and packaging suppliers are assessed for cGMP compliance. Approved vendors undergo regular audits to ensure consistent supply quality and alignment with Taj Pharma’s expectations.
  • Mock Inspections & Readiness Drills: Periodic simulation of regulatory inspections helps keep the plant and personnel prepared for real audits by authorities such as USFDA, EMA, WHO, and others.
  • GMP Training & Awareness Programs: All employees are regularly trained on the latest cGMP updates, good documentation practices (GDP), and data integrity to promote a culture of quality and accountability.

Taj Pharma’s total cGMP compliance model is not just a regulatory requirement—it is a strategic commitment to quality, safety, and global trust. Through continuous improvement, stringent internal controls, and alignment with international standards, Taj Pharma ensures that all pharmaceutical products manufactured at the Sarigam facility meet the highest levels of purity, potency, and patient safety. This positions the company as a preferred CMO/CDMO partner for global pharmaceutical and healthcare organizations.


2. Documentation & Batch Review

  • All manufacturing activities are governed by Standard Operating Procedures (SOPs).
  • QA is responsible for reviewing and approving:
    • Batch Manufacturing Records (BMRs)
    • Batch Packaging Records (BPRs)
    • Deviation reports
    • Change controls
  • Every product batch is only released after comprehensive documentation review and QA clearance.

At Taj Pharma’s Sarigam facility, documentation and batch review serve as a cornerstone of Quality Assurance (QA), ensuring that each pharmaceutical product meets regulatory, safety, and efficacy standards before it reaches the market.


Governance through Standard Operating Procedures (SOPs)

Every step of manufacturing—from raw material dispensing to packaging and final batch release—is strictly guided by Standard Operating Procedures (SOPs). These SOPs are:

  • Developed in alignment with WHO-GMP, PIC/S, and EU-GMP guidelines
  • Periodically reviewed, updated, and approved by QA
  • Designed to ensure consistency, minimize human error, and maintain traceability

Critical QA Responsibilities in Documentation Oversight

The QA department plays a pivotal role in reviewing, verifying, and approving essential documents that track batch history and ensure regulatory compliance. These include:

Batch Manufacturing Records (BMRs)

BMRs document the entire production process—equipment used, personnel involved, process parameters, in-process controls, and yield reconciliation. QA reviews BMRs for:

  • Completeness and legibility
  • GMP compliance
  • Deviations or discrepancies
  • Cross-verification with production logs

Batch Packaging Records (BPRs)

BPRs provide details of packaging activities—packaging materials used, batch codes, label accuracy, serialization data, and reconciliation of packaging components. QA checks for:

  • Proper labeling and coding
  • Serialization compliance (Track & Trace)
  • Packaging material integrity and usage records

Deviation Reports

Any non-conformance to a predefined process or SOP is logged as a deviation. QA ensures that:

  • Deviations are clearly described and justified
  • Root cause analysis (RCA) is conducted
  • Corrective and Preventive Actions (CAPA) are identified and implemented
  • Deviation closure is properly documented

Change Control Forms

Changes to equipment, process parameters, analytical methods, or documents must go through a formal change control system. QA assesses:

  • Impact on product quality
  • Need for re-validation or re-training
  • Justification and risk evaluation
  • Approval before implementation

Batch Release Authorization

A batch cannot be released for sale or distribution unless:

  • All BMRs and BPRs are thoroughly reviewed
  • Deviations (if any) are resolved and documented
  • Analytical testing results meet specifications
  • Environmental monitoring records are satisfactory
  • Final clearance is issued by the QA Head or designee

This comprehensive review process ensures data integrity, traceability, regulatory compliance, and patient safety.


Taj Pharma’s Documentation & Batch Review system is built on a foundation of accountability, transparency, and regulatory rigor. It is not just a record-keeping function—it is an active, quality-driven process that ensures every batch released from the Sarigam plant is safe, effective, and globally compliant.


3. In-Process Quality Assurance (IPQA)

IPQA teams are present on the shop floor, conducting:

  • Line clearance
  • Environmental monitoring
  • In-process checks (e.g., tablet hardness, weight variation, fill volume, etc.)
  • Sampling and documentation verification

This real-time monitoring ensures that any deviation is immediately identified, corrected, and documented.

In-Process Quality Assurance (IPQA) is a core function of the QA department at Taj Pharma’s Sarigam facility, serving as a proactive layer of quality control embedded directly into the manufacturing process. Rather than relying solely on end-product testing, IPQA ensures that quality is built into each stage of production—from the moment raw materials enter the cleanroom to final product packaging.


Real-Time Oversight on the Shop Floor

IPQA personnel are physically stationed within the manufacturing and packaging areas, operating under a proactive quality surveillance model. Their responsibilities are essential to ensuring cGMP compliance, traceability, and timely issue resolution.


Key Responsibilities of the IPQA Team

1. Line Clearance

Before any batch activity begins, IPQA conducts thorough line clearance to ensure:

  • Equipment and area are clean and free from residues
  • Previous batch/product materials are removed
  • Correct batch documents and labels are in place
  • Area is prepared for safe and compliant operation

Only after IPQA grants clearance can the production team proceed.


2. Environmental Monitoring (EM)

IPQA conducts routine and spot checks for environmental parameters like:

  • Temperature and humidity control
  • Airborne particulate count (especially in ISO-classified areas)
  • Surface cleanliness and personnel hygiene compliance

This is critical for maintaining a contamination-free and controlled environment, especially for OSD and external preparations.


3. In-Process Checks

Throughout production and packaging, IPQA monitors critical quality attributes (CQAs) such as:

  • Tablet hardness, friability, thickness, and disintegration time
  • Weight variation of tablets/capsules
  • Fill volume in syrups or oral suspensions
  • Sealing integrity in sachets, tubes, and bottles
  • Label accuracy, batch printing, and serialization

These checks are conducted at defined intervals and stages to detect any deviations early—preventing defective products from progressing further.


4. Sampling & Documentation Verification

IPQA is responsible for:

  • Collecting in-process and finished product samples for laboratory analysis
  • Ensuring sampling follows statistically valid protocols (per ICH Q6A)
  • Verifying real-time documentation entries in BMRs and BPRs
  • Checking logbooks and ensuring contemporaneous data recording

Deviation Management and Immediate Interventions

Should any deviation, anomaly, or out-of-specification (OOS) result be detected:

  • IPQA halts the process immediately (if required)
  • Initiates a Deviation Report with root cause analysis (RCA)
  • Coordinates with Production, QA, and QC teams for prompt Corrective and Preventive Actions (CAPA)
  • Ensures the incident is documented and closed as per SOPs

Taj Pharma’s IPQA system functions as the first line of defense in maintaining product quality and regulatory compliance. By embedding quality checks into every stage of production, IPQA safeguards product integrity, improves batch consistency, and minimizes the risk of costly recalls or rejections. It reflects Taj Pharma’s commitment to real-time quality assurance and operational excellence.


4. Process Validation & Qualification

  • QA manages the entire validation lifecycle:
    • Process validation
    • Cleaning validation
    • Equipment qualification (IQ, OQ, PQ)
  • Validation master plans (VMPs) are maintained and aligned with international standards, ensuring reproducible product quality across batches.

At Taj Pharma’s Sarigam facility, Process Validation and Equipment Qualification are integral components of the Quality Assurance (QA) framework, ensuring that every process, piece of equipment, and cleaning method consistently delivers results that meet predefined quality standards. This system is built in full alignment with WHO-GMP, EU-GMP, PIC/S, and ICH Q8–Q11 guidelines.


🔍 End-to-End Validation Lifecycle Management

Taj Pharma’s QA department is responsible for planning, executing, and maintaining the entire validation lifecycle. This includes:


1. Process Validation (PV)

PV confirms that a manufacturing process consistently produces a product that meets specifications and quality attributes.

  • Conducted on pilot and commercial-scale batches
  • Covers Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
  • Includes media fill trials (for sterile or aseptic processes where applicable)
  • Involves statistical data analysis, sampling plans, and reproducibility checks
  • Supports Technology Transfer and New Product Introductions (NPIs)

2. Cleaning Validation

Ensures that cleaning procedures effectively remove product residues, detergents, and microbial contaminants to prevent cross-contamination.

  • Validation performed for shared and dedicated equipment
  • Includes Worst-Case Product Selection
  • Swab and rinse tests verified using validated analytical methods
  • Ensures compliance with Residue Acceptance Limits (RALs) and MACO (Maximum Allowable Carryover) standards

3. Equipment Qualification

Each major equipment and utility system undergoes a structured qualification process:

  • Installation Qualification (IQ): Verifies that equipment is installed as per design and specifications
  • Operational Qualification (OQ): Confirms the equipment performs correctly across operational ranges
  • Performance Qualification (PQ): Validates that equipment performs consistently under real-world conditions and actual loads

This applies to:

  • Blenders, tablet presses, granulators
  • Packaging lines, HVAC systems
  • Water systems (WFI/RO), clean utilities

4. Validation Master Plan (VMP)

A Validation Master Plan (VMP) is maintained and regularly updated by QA to outline the validation strategy for the facility. It includes:

  • Scope of validation and re-validation
  • Risk assessment procedures (FMEA, HACCP)
  • Roles and responsibilities
  • Qualification schedules for new or modified systems
  • Periodic review timelines and requalification criteria

The VMP ensures structured and documented validation planning, supporting regulatory readiness.


Regulatory Alignment

All validation activities are conducted in alignment with:

  • ICH Q8 (Pharmaceutical Development)
  • ICH Q9 (Quality Risk Management)
  • ICH Q10 (Pharmaceutical Quality System)
  • EU Annex 15 for Qualification and Validation
  • 21 CFR Part 11 compliance for electronic records and signatures

The Process Validation & Qualification program at Taj Pharma ensures that every product is manufactured under controlled, consistent, and verifiable conditions. By managing this lifecycle through QA oversight, Taj Pharma demonstrates its commitment to product quality, regulatory compliance, and patient safety—hallmarks of a world-class pharmaceutical manufacturing facility.


5. Supplier and Raw Material Qualification

  • QA is involved in vendor qualification and audit to ensure materials come from approved, reliable sources.
  • Every Active Pharmaceutical Ingredient (API) and excipient is qualified and periodically re-evaluated based on risk.

Taj Pharma OSD & External Preparation Plant – Quality Assurance (QA)

At Taj Pharma’s Sarigam facility, Supplier and Raw Material Qualification is a critical QA-led function that ensures all raw materials, including Active Pharmaceutical Ingredients (APIs) and excipients, are consistently sourced from approved, compliant, and reliable suppliers. This process directly contributes to the safety, quality, and efficacy of the final pharmaceutical products.


🔍 1. Supplier Qualification & Audit Program

Taj Pharma maintains a robust vendor qualification system, managed by QA, which includes:

  • Initial Qualification:
    Evaluation of new suppliers based on regulatory compliance history, certifications (e.g., WHO-GMP, CEP, USFDA), and quality agreements.
  • On-site Audits:
    Risk-based audits are conducted at supplier facilities by a trained QA audit team to assess manufacturing practices, quality systems, and traceability.
  • Documentation Review:
    Evaluation of Drug Master Files (DMFs), Certificates of Analysis (COAs), Method of Analysis (MOAs), and stability data.
  • Approval Status:
    Suppliers are classified as Approved, Conditionally Approved, or Rejected, based on audit outcomes and quality performance.

🧪 2. Raw Material Qualification (API & Excipients)

Every incoming raw material undergoes a strict qualification process:

  • Sampling & Testing:
    Each batch is sampled in a controlled environment and tested by QC as per pharmacopeial standards (IP, BP, USP, EP).
  • Certificate of Analysis (COA) Verification:
    Supplier COAs are cross-verified with in-house results for identity, purity, assay, and microbiological parameters.
  • Risk-Based Assessment:
    Materials are classified based on their criticality (e.g., moisture-sensitive APIs, high-potency actives) and evaluated accordingly.
  • Stability & Compatibility:
    Materials undergo compatibility and stability studies if used in new or sensitive formulations.

🔁 3. Periodic Re-Evaluation

Approved suppliers and raw materials are not static. QA conducts:

  • Annual/bi-annual reviews of supplier performance based on:
    • Out-of-spec (OOS) incidents
    • Deviations or non-conformances
    • Complaint history
    • On-time delivery and documentation quality
  • Requalification audits, triggered by changes in the supplier’s operations, regulatory status, or significant quality incidents.

4. Compliance with Global Standards

Taj Pharma’s Supplier Qualification program is designed in accordance with:

  • ICH Q7: GMP for Active Pharmaceutical Ingredients
  • WHO-GMP, EU-GMP, PIC/S, and ISO 9001:2018 requirements
  • 21 CFR Part 210/211 (as applicable for export markets)
  • Guidelines for traceability, supply chain transparency, and counterfeit prevention

By ensuring that all materials used in production are qualified, traceable, and sourced from reliable and compliant vendors, Taj Pharma’s QA team reinforces the foundation of quality in every finished product. This approach not only reduces risks but also strengthens supply chain integrity, global regulatory acceptance, and patient safety.


6. Training & Compliance Monitoring

  • QA oversees GMP training programs for all staff—new and existing—on:
    • SOP compliance
    • Data integrity
    • Good documentation practices (GDP)
  • Periodic compliance audits are conducted to ensure all departments follow the latest protocols.

At Taj Pharma’s Sarigam facility, the Quality Assurance (QA) department plays a pivotal role in fostering a culture of compliance, quality, and continuous learning through structured training programs and ongoing compliance monitoring. These activities ensure that all personnel—from production to QC to warehousing—are fully aligned with cGMP principles, global regulatory requirements, and internal SOPs.


🎓 Structured GMP Training Programs

QA is responsible for organizing and maintaining comprehensive training modules, tailored to various functional roles within the plant. Training programs include:

1. Induction Training

  • Conducted for all new employees, covering:
    • Introduction to cGMP and GDP
    • Company quality policies
    • Basic hygiene, safety, and documentation practices

2. Role-Specific Technical Training

  • Operators and supervisors are trained in:
    • Equipment-specific SOPs
    • Cleanroom behavior
    • In-process quality checks
    • Batch documentation protocols

3. GMP Refreshers & Regulatory Updates

  • Regular refresher sessions for existing staff
  • Covers changes in global GMP (WHO, EU, PIC/S) and internal SOP revisions

📝 Training on Core Quality Systems

Special emphasis is placed on:

  • Standard Operating Procedure (SOP) Compliance:
    Understanding, adherence, and documentation of every step as per approved SOPs
  • Good Documentation Practices (GDP):
    Legible, traceable, contemporaneous entries; corrections, cross-outs, and use of ink as per SOP
  • Data Integrity (DI):
    ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available

🔄 Competency Assessment & Certification

  • Post-training evaluations through written tests, interviews, or hands-on assessments
  • Employees are certified as competent only after successful evaluation
  • Training records are digitally logged and auditable, ensuring traceability

🔍 Compliance Monitoring & Internal Audits

QA conducts periodic compliance audits across all departments to assess:

  • Adherence to SOPs and cGMP
  • Use of correct batch documents and logbooks
  • Cleanroom behavior and gowning protocols
  • Environmental monitoring and equipment calibration compliance

Findings from audits trigger:

  • Corrective and Preventive Actions (CAPA)
  • Retraining sessions, if gaps in knowledge or execution are observed
  • Updates to SOPs and training modules if systemic issues are identified

🛡️ Regulatory Alignment

All training and monitoring activities are aligned with:

  • ICH Q10 (Pharmaceutical Quality System)
  • WHO-GMP, EU-GMP, PIC/S, and ISO 9001:2018 training standards
  • Readiness for audits by agencies such as USFDA, MHRA, and local MOHs

By implementing structured, role-specific training and real-time compliance monitoring, the QA department at Taj Pharma ensures that its workforce is competent, compliant, and audit-ready. This ongoing investment in people and process excellence strengthens Taj Pharma’s position as a globally trusted pharmaceutical manufacturing partner.


7. Product Release & Regulatory Liaison

  • QA coordinates with Regulatory Affairs to ensure that all production meets the requirements of the marketing authorization (MA) or regulatory dossier (CTD/ACTD).
  • Finished product release is performed only after verifying:
    • Analytical test results
    • Microbiological clearance (where applicable)
    • Packaging integrity
    • Labeling and serialization compliance

At Taj Pharma’s Sarigam manufacturing facility, the Quality Assurance (QA) team plays a vital gatekeeping role in ensuring that every product released into the market meets stringent regulatory, quality, and safety standards. This is achieved through a robust product release process that is tightly integrated with Regulatory Affairs (RA) and supported by meticulous documentation, testing, and compliance protocols.


🧾 Coordinated Regulatory Alignment

Before product release, QA collaborates closely with the Regulatory Affairs team to ensure:

  • All processes align with the registered Marketing Authorization (MA)
  • The product specifications match those submitted in CTD/ACTD dossiers
  • Manufacturing and packaging comply with country-specific regulatory guidelines (e.g., USFDA, EMA, WHO, Gulf MOH, etc.)

This ensures global compliance, audit readiness, and smooth market approvals across multiple geographies.


Comprehensive Product Release Protocol

A finished product is only released for sale or export after thorough verification of the following criteria:

1. Analytical Test Results

  • Review of Finished Product Specifications (FPS)
  • All critical quality attributes (CQAs) are within specified limits
  • Analytical reports validated and signed by QC and QA

2. Microbiological Clearance

  • For non-sterile and sterile products, microbial load testing is performed
  • Includes total viable count (TVC), absence of pathogens, and for injectables: sterility and endotoxin testing
  • Product is held in quarantine until clearance is granted

3. Packaging Integrity

  • Visual and mechanical inspection of:
    • Sealing, blistering, bottle torque
    • Correctness of batch number, expiry date, and product info
  • Cartons and shipper boxes verified for physical damage and tamper evidence

4. Labeling and Serialization Compliance

  • Verification of:
    • Correct artwork version (per regulatory submission)
    • Country-specific labeling (language, barcode, font)
    • 2D barcoding and serialization for track & trace compliance (especially for EU FMD, DSCSA)

📤 Final QA Clearance

Only after satisfactory review of all data, including:

  • Batch Manufacturing Records (BMR)
  • Batch Packaging Records (BPR)
  • Deviation/Change Control reports (if applicable)

The QA Head issues a formal Batch Release Certificate (BRC).

The product can then be moved from quarantine to Finished Goods and is cleared for dispatch.


📡 Ongoing Liaison with Regulatory Affairs

QA maintains:

  • Change communication logs to inform RA of any manufacturing or packaging modifications
  • Audit trails and logs to support regulatory inspections
  • Cross-verification of export documentation, product inserts, and CoAs against dossier submissions

Taj Pharma’s rigorous Product Release & Regulatory Liaison system ensures that every product shipped from the Sarigam facility:

  • Meets international regulatory expectations
  • Upholds patient safety
  • Maintains the integrity and reputation of clients and marketing partners

This robust QA-RA synergy cements Taj Pharma’s standing as a globally trusted pharmaceutical contract manufacturer.


8. Data Integrity and Electronic Compliance

  • QA ensures compliance with ALCOA+ principles:
    • Attributable, Legible, Contemporaneous, Original, Accurate
    • Plus: Complete, Consistent, Enduring, and Available
  • Electronic systems like LIMS, ERP, and SCADA are validated and managed in compliance with 21 CFR Part 11 and Annex 11 requirements for data integrity.

At Taj Pharma’s Sarigam manufacturing facility, data integrity is not just a regulatory requirement—it is a fundamental pillar of our Quality Management System (QMS). The QA department ensures that all data, whether recorded on paper or electronically, is accurate, secure, and trustworthy—providing a solid foundation for product quality, compliance, and regulatory acceptance.


🔐 ALCOA+ Framework Compliance

Taj Pharma strictly adheres to the ALCOA+ principles, which are globally recognized for good data management practices:

  • A – Attributable: Every data entry must be traceable to the individual who created or modified it, including timestamps and login credentials.
  • L – Legible: Data must be readable and recorded in a durable medium, whether electronic or paper-based.
  • C – Contemporaneous: Data is recorded at the time the activity occurs, not afterward.
  • O – Original: The data must be the first capture (original record), not transcribed or copied from another source.
  • A – Accurate: Data must be free from error, with checks and calibrations to ensure correctness.

PLUS:

  • Complete: All data—including any changes or corrections—must be retained.
  • Consistent: Data must follow a logical order with consistent formats, units, and terminology.
  • Enduring: Data must be preserved over the product’s life cycle, audit-ready at all times.
  • Available: Records must be readily retrievable when needed, especially during audits or inspections.

💻 Validated Electronic Systems

Taj Pharma employs a suite of 21 CFR Part 11 and EU Annex 11 compliant systems to manage and safeguard electronic records:

1. LIMS (Laboratory Information Management System)

  • Handles QC test data, analytical results, and instrument integration
  • Ensures traceability and audit trails for all test outcomes

2. ERP (Enterprise Resource Planning)

  • Integrates warehouse, inventory, procurement, and production data
  • Maintains real-time traceability from raw material receipt to finished product dispatch

3. SCADA (Supervisory Control and Data Acquisition)

  • Manages and monitors real-time operations across HVAC, cleanroom parameters, and utilities
  • Captures environmental data and alarm logs that are critical for compliance

4. EMS/BMS (Environmental/Building Management Systems)

  • Provides continuous monitoring of temperature, humidity, pressure differentials, and particulate matter
  • Automatically logs and stores values with defined thresholds and alerts

📑 System Validation & Control

All electronic systems at Taj Pharma are subjected to:

  • Computer System Validation (CSV) protocols
  • User access control to prevent unauthorized changes
  • Audit trails and backup management
  • Regular SOP training for operators and QA reviewers

This ensures that systems are secure, user-responsible, and tamper-evident—capable of standing up to global regulatory scrutiny.


🛡️ Regulatory Compliance Alignment

Taj Pharma’s Data Integrity framework is aligned with:

  • USFDA 21 CFR Part 11
  • EU Annex 11
  • MHRA Data Integrity Guidance
  • WHO Technical Report Series on Data Integrity
  • PIC/S PI 041 guidelines

By embedding ALCOA+ principles and advanced electronic data management across operations, Taj Pharma ensures that every batch record, QC result, and audit trail is credible, compliant, and traceable—reinforcing our commitment to product quality, patient safety, and regulatory excellence.


The Quality Assurance Department at Taj Pharma’s Sarigam OSD & External Preparation Plant ensures that every product reaching patients worldwide is safe, effective, and compliant with stringent global standards. By embedding quality into every process—from raw material sourcing to final product release—Taj Pharma reinforces its commitment to excellence in pharmaceutical manufacturing.